Variceal BleedingPhase 4NCT00965900
Endoscopic Band Ligation (EBL) Versus Propranolol for Primary Prophylaxis of Variceal Bleeding
A Phase 4 study testing Endoscopic band ligation, Propranolol and EBL+Propranolol in people with Variceal Bleeding and Cirrhosis, run by Korea University at 1 site in South Korea.
Trial summary
This study is performed to compare the efficacy and safety of EBL, propranolol, and EBL combined with propranolol in patients with medium or large varices. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Variceal Bleeding, Cirrhosis
- What is being tested?
- Endoscopic band ligation, Propranolol and EBL+Propranolol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2006to May 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Liver cirrhosis
- Age between 18 and 70 years
- Esophageal varices with high bleeding risk: more than F2 and red color sign
- No previous history of upper gastrointestinal bleeding
- No previous history of endoscopic, radiologic, or surgical therapy for varices or ascites
- Do not take beta-blocker, ACE inhibitor, or nitrate
- Child-Pugh score <12
Who cannot join
- Patients with systolic blood pressure <100 mmHg or basal heart rate <60/min
- Portal vein thrombosis
- Uncontrolled ascites or hepatic encephalopathy
- Severe coagulation disorder: prothrombin time <40% (or INR >1.7) or platelet count <30,000/mm3
- Medium or large sized gastric or duodenal varices
- Coexisting malignancy
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- Severe cardiovascular disorder, renal failure, peritonitis, sepsis
- Severe erosive esophagitis, severe esophageal stricture, active gastric or duodenal ulcer
- Contraindication to beta-blocker
- Pregnancy
- Refusal to give consent to participate in the trial
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Korea University Anam Hospital
Seoul, 136-705
About this study
Official title: Randomized Controlled Trial Comparing Propranolol, Endoscopic Banding Ligation, and Combined Treatment to Prevent First Variceal Hemorrhage in Patients With Liver Cirrhosis
This study is performed to compare the efficacy and safety of EBL, propranolol, and EBL combined with propranolol in patients with medium or large varices.
Read the detailed description
Current guidelines recommend prophylactic treatment with propranolol or endoscopic band ligation (EBL) to prevent variceal bleeding in patients with medium or large varices. However, it is unclear which treatment is more useful in regard to prevention of variceal bleeding as well as safety. In addition, the efficacy and safety of the combination of EBL and propranolol is not still defined. This study is performed to compare the efficacy and safety of EBL, propranolol, and EBL combined with propranolol in patients with medium or large varices.
- Conditions
- Variceal Bleeding, Cirrhosis
- Being tested
- Endoscopic band ligation, Propranolol, EBL+Propranolol
- Keywords
- Cirrhosis, Esophagus Disorders, Varicose Veins
- Medical subject headings
- Fibrosis, Esophageal Diseases, Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic band ligationProcedure or surgery
Also called EBL
- Perform EBL within 7 days after randomization
- Apply 1-2 band/column/session to varices in the distal 5-7 cm of the esophagus till they are eradicated (disappearance or too small to apply band) with interval of 4 weeks (at 4,8,12 weeks after initial treatment)
- Acid suppression using proton pump inhibitor until eradicated.
- After eradication, then follow-up endoscopy according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3-6 months until 36 months).
PropranololDrug
Also called Beta blocker
- start with 20 mg of propranolol b.i.d
- Adjust by 20-40 mg/day reaching reduction by 25 percent in HR or HR less than 55/min
- After reaching target HR, then FU according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3 months until 36 months)
EBL+PropranololProcedure or surgery
Also called EBL+Beta blocker
- EBL
- Perform EBL within 7 days after randomization
- Apply 1-2 band/column/session to varices in the distal 5-7 cm of the esophagus till they are eradicated (disappearance or too small to apply band) with interval of 4 weeks (at 4,8,12 weeks after initial treatment)
- Acid suppression using proton pump inhibitor until eradicated.
- After eradication, then follow-up endoscopy according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3-6 months until 36 months).
- Propranolol
- start with 20 mg b.i.d
- Adjust by 20-40 mg/day reaching reduction by 25 percent in HR or HR less than 55/min
- After reaching target HR, then FU according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3 months until 36 months)
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic band ligation | Active comparator | Endoscopic band ligation until eradication of esophageal varices with 4 weeks interval, and then follow-up endoscopy with 3-6 months interval until 36 months after enrollment Receives: Procedure: Endoscopic band ligation |
| Propranolol | Active comparator | start with 20 mg b.i.d, and adjust by 20-40 mg/d reaching reduction by 25% in HR or HR ≤55/min. After reaching target HR, then follow-up according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3 months until 36 months) Receives: Drug: Propranolol |
| EBL+Propranolol | Active comparator | * EBL until eradication of esophageal varices with 4 weeks interval, and then follow-up endoscopy with 3-6 months interval until 36 months after enrollment
* start with 20 mg of propranolol b.i.d, and adjust by 20-40 mg/d reaching reduction by 25% in HR or HR ≤55/min. After reaching target HR, then follow-up according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3 months until 36 months) Receives: Procedure: EBL+Propranolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
First esophageal variceal bleeding
First esophageal variceal bleeding after enrollment
Measured: 3 years after enrollment
Secondary outcomes (1)
Mortality; Significant esophageal variceal bleeding; Upper gastrointestinal bleeding except esophageal bleeding; Adverse events
Mortality; Significant esophageal variceal bleeding; Upper gastrointestinal bleeding except esophageal bleeding; Adverse events
Measured: 3 years after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2009 (estimated)
- Study startSep 2006
- Primary completionMay 2019 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Variceal BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soon Ho Um, Korea University
- Investigators
- Soon Ho Um, Prof, Principal investigator, Korea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00965900
- Sponsor's protocol ID
- RCTPEBL
- Status last verified
- Aug 2017
- First submitted
- 25 Aug 2009
- Last updated
- 23 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Propranolol, Endoscopic Banding Ligation, and Combined Treatment to Prevent First Variceal Hemorrhage in Patients With Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT00965900
- Acronym / sponsor ID
- RCTPEBL
- Conditions
- Variceal Bleeding, Cirrhosis
- Keywords
- Cirrhosis, Esophagus Disorders, Varicose Veins
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- Korea UniversityUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 26 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is performed to compare the efficacy and safety of EBL, propranolol, and EBL combined with propranolol in patients with medium or large varices.
Detailed description
Current guidelines recommend prophylactic treatment with propranolol or endoscopic band ligation (EBL) to prevent variceal bleeding in patients with medium or large varices. However, it is unclear which treatment is more useful in regard to prevention of variceal bleeding as well as safety. In addition, the efficacy and safety of the combination of EBL and propranolol is not still defined. This study is performed to compare the efficacy and safety of EBL, propranolol, and EBL combined with propranolol in patients with medium or large varices.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Endoscopic band ligation | Active comparator | Procedure: Endoscopic band ligationEndoscopic band ligation until eradication of esophageal varices with 4 weeks interval, and then follow-up endoscopy with 3-6 months interval until 36 months after enrollment |
| Propranolol | Active comparator | Drug: Propranololstart with 20 mg b.i.d, and adjust by 20-40 mg/d reaching reduction by 25% in HR or HR ≤55/min. After reaching target HR, then follow-up according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3 months until 36 months) |
| EBL+Propranolol | Active comparator | Procedure: EBL+Propranolol* EBL until eradication of esophageal varices with 4 weeks interval, and then follow-up endoscopy with 3-6 months interval until 36 months after enrollment * start with 20 mg of propranolol b.i.d, and adjust by 20-40 mg/d reaching reduction by 25% in HR or HR ≤55/min. After reaching target HR, then follow-up according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3 months until 36 months) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Liver cirrhosis
- Age between 18 and 70 years
- Esophageal varices with high bleeding risk: more than F2 and red color sign
- No previous history of upper gastrointestinal bleeding
- No previous history of endoscopic, radiologic, or surgical therapy for varices or ascites
Key exclusion criteria (11 listed)
- Patients with systolic blood pressure <100 mmHg or basal heart rate <60/min
- Portal vein thrombosis
- Uncontrolled ascites or hepatic encephalopathy
- Severe coagulation disorder: prothrombin time <40% (or INR >1.7) or platelet count <30,000/mm3
- Medium or large sized gastric or duodenal varices
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic band ligationAlso: EBL* Perform EBL within 7 days after randomization * Apply 1-2 band/column/session to varices in the distal 5-7 cm of the esophagus till they are eradicated (disappearance or too small to apply band) with interval of 4 weeks (at 4,8,12 weeks after initial treatment) * Acid suppression using proton pump inhibitor until eradicated. * After eradication, then follow-up endoscopy according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3-6 months until 36 months). | Procedure or surgery | Endoscopic band ligation |
| PropranololAlso: Beta blocker* start with 20 mg of propranolol b.i.d * Adjust by 20-40 mg/day reaching reduction by 25 percent in HR or HR less than 55/min * After reaching target HR, then FU according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3 months until 36 months) | Drug | Propranolol |
| EBL+PropranololAlso: EBL+Beta blocker1. EBL * Perform EBL within 7 days after randomization * Apply 1-2 band/column/session to varices in the distal 5-7 cm of the esophagus till they are eradicated (disappearance or too small to apply band) with interval of 4 weeks (at 4,8,12 weeks after initial treatment) * Acid suppression using proton pump inhibitor until eradicated. * After eradication, then follow-up endoscopy according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3-6 months until 36 months). 2. Propranolol * start with 20 mg b.i.d * Adjust by 20-40 mg/day reaching reduction by 25 percent in HR or HR less than 55/min * After reaching target HR, then FU according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3 months until 36 months) | Procedure or surgery | EBL+Propranolol |
Primary outcome
First esophageal variceal bleeding
Time frame: 3 years after enrollment
First esophageal variceal bleeding after enrollment
1 secondary outcome
Mortality; Significant esophageal variceal bleeding; Upper gastrointestinal bleeding except esophageal bleeding; Adverse events
Time frame: 3 years after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soon Ho Um, Prof principal investigator
Korea University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Endoscopic band ligation, Propranolol and EBL+Propranolol in people with Variceal Bleeding and Cirrhosis, run by Korea University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Soon Ho Um, Prof (82-2-920-5019, umsh@korea.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First esophageal variceal bleeding (time frame: 3 years after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2017.